化学发光和酶免2种检测系统检测HBsAg情况分析  

Analysis of HBsAg detected by chemiluminescence immunoassay and enzyme-linked immunosorbent assay

作　　者：王新梅[1] 臧亮[1] 邓雪莲[1] 李春祥[1] 孙鹏 WANG Xinmei;ZANG Liang;DENG Xuelian;LI Chunxiang;SUN Peng(Dalian Blood Center,Dalian China,116001)

机构地区：[1]大连市血液中心,辽宁大连116001

出　　处：《中国输血杂志》2020年第3期222-226,共5页Chinese Journal of Blood Transfusion

摘　　要：目的通过对日常献血者标本(3031份)和血清盘的平行检测,评估化学发光(CLIA)和酶免(ELISA)2个检测系统检测HBsAg各项性能指标。方法分别采用ELISA(国产A试剂)、ELISA(进口B试剂)和CLIA(国产)对3031份日常献血者标本进行HBsAg的检测,将阳性标本送卫生部临检中心进行确认实验;分别采用ELISA2种厂家试剂和CLIA(国产)对HBsAg血清盘进行平行检测,将上述数据汇总整理分析,比较ELISA和CLIA2种检测体系的灵敏度、特异性、阳性预期值、批内与批间精密度以及不同血清型标本和突变株的检出能力等指标。结果ELISA与CLIA平行检测日常献血者标本(3031份)复检符合率CLIA(国产)为83.33%、ELISA(进口B试剂)为33.33%、ELISA(国产A试剂)为14.28%,CLIA高于ELISA(2种试剂)且P<0.01。ELISA和CLIA平行检测HBsAg血清盘情况:CLIA本中心实验室与其它实验室整体检测的灵敏度、特异性、阳性预期值,P>0.05。ELISA(国产A)和CLIA(国产)的灵敏度分别为77.39%和89.17%,P<0.05,阳性预期值和特异性,P>0.05;ELISA(进口B)和CLIA(国产)的灵敏度、特异性、阳性预期值,P>0.05。A盘弱阳性质控批内CV:CLIA(4.869%)<A(7.269%)<B(8.428%);H盘弱阳性质控批内CV:CLIA(4.949%)<B(7.157%)<A(13.712%);H盘强阳性质控批内CV:CLIA(4.486%)<B(11.543%)<A(46.454%)。弱阳性质控批间CV:CLIA(8.108%)<B(15.288%)<A(33.585%);强阳性质控批间CV:CLIA(6.410%)<A(10.285%)<B(12.673%)。血清盘HBV 3种血清型ayw1、adw2和adrq+的检出下限分别为:CLIA(国产)0.09 IU/mL、0.05 IU/mL、0.05 IU/mL;ELISA(进口B试剂)均为0.05 IU/mL;ELISA(国产A试剂)为0.18 IU/mL、0.09 IU/mL、0.05 IU/mL。针对HBsAg突变类型的检测能力多家血站整体数据显示,应用进口试剂的ELISA检测系统要优于应用国产试剂的CLIA检测系统。结论对于HBsAg的检测虽然从方法学上化学发光要优于酶联免疫,但是从我们的评估情况看其各项性能指标的检测水平2种检测系统却各有优劣,由此可见Objective The evaluate the performance of HBsAg chemiluminescence immunoassay(CLIA)and HBsAg enzyme-linked immunosorbent assay(ELISA)system by parallel detection of blood donor samples(n=3031)and blood serum plates.Methods Domestic ELISA reagent A(referred as reagent A),imported ELISA reagent B(referred as reagent B)and domestic CLIA reagent were used for the serological detection of HBsAg of hepatitis B virus(HBV)in 3031 routine samples from blood donors.The HBsAg positive samples were sent to National Center for Clinical Laboratories(NCCL)for confirmation.Reagent A/B and reagent CLIA were also used to detect HBsAg serum plates in parallel.All data collected was analyzed to evaluate the sensitivity,specificity,positive predictive value,intra/inter-assay precision and mutant detecting ability of each system.Results 1)For 3031 routine samples from blood donors,the concordance rates of retesting using domestic CLIA reagent(83.33%)was significantly higher than that of reagent B(33.33%)and reagent A(14.28%)(P<0.01).2)The results of HBsAg serum plates detected by ELISA and CLIA in parallel were as follows:①No significant difference was observed in the sensitivity,specificity and positive predictive value of CLIA between our laboratory and the others(P>0.05).②The sensitivity of reagent A(77.39%)was significantly lower than that of CLIA reagent(89.17%)(P<0.05),however,no significant difference in the specificity and positive predictive value was observed between them(P>0.05).No significant difference was observed neither in sensitivity,specificity nor positive predictive value between reagent B and CLIA reagent(P>0.05).③The intra-assay CV of weakly positive QC samples in A serum plate was as follows:CLIA reagent(4.869%)<reagent A(7.269%)<reagent B(8.428%);that of weakly positive QC in H serum plate was CLIA reagent(4.949%)<reagent B(7.157%)<reagent A(13.712%);that of strongly positive QC in H serum plate was CLIA reagent(4.486%)<reagent B(11.543%)<reagent A(46.454%).The inter-assay CV of weakly positive QC was CLI

关 键 词：化学发光免疫分析法 酶联免疫法 乙型肝炎表面抗原 性能指标 

分 类 号：R446.112[医药卫生—诊断学] R512.62[医药卫生—临床医学]